Description of Pantera Lux paclitaxel-releasing balloons and preliminary quantitative coronary angiography (QCA) results at six months in patients with coronary in-stent restenosis

作者：Hehrlein Christoph^*; Richardt Gert; Wiemer Marcus; Schneider Henrik; Naber Christoph; Hoffmann Ellen; Dietz Ulrich

来源：Eurointervention, 2011, 7: K119-K124.

• drug-eluting balloon
• drug-eluting stent
• bare metal stent
• in-stent restenosis
• revascularisation
• late lumen loss

Aims: Drug-eluting balloons (DEB) have recently emerged as a valuable treatment option for patients with coronary in-stent restenosis (ISR). However, little information exists on results of DEB therapy of in-stent restenosis from drug-eluting stents (DES).
Methods and results: The Pantera Lux balloon catheter, a novel DEB releasing paclitaxel with a BTHC matrix was studied in a prospective, multicentre first-in-man trial of patients with ISR either from bare metal stents (BMS) or drug-eluting stents (DES). Here we report on the clinical and angiographic follow-up of the first 45 Pantera Lux patients after six months. The mean age (+/- SD) of the studied ISR patients was 69 +/- 9 years (82% males, 18% females). The distribution of BMS and DES in these patients was 53% and 47%, respectively. Success of deployment of the device was 100%. After six months, the major adverse cardiac event (MACE) rate was 7.7% including one post-procedural non-fatal myocardial infarction, one target lesion- and one target vessel- revascularisation (each clinically driven). Angiographic in-stent late lumen loss was 0.03 +/- 0.35 mm (BMS: -0.08 +/- 0.37 mm, DES: 0.15 +/- 0.28 mm) as assessed by an independent angiographic core laboratory.
Conclusion: Treatment of coronary in-stent restenosis with the Pantera Lux paclitaxel-releasing balloon catheter shows very promising preliminary 6-month results, irrespective of whether the initially implanted stent was a bare metal- or a drug-eluting stent.

• 出版日期2011-5